Aspen® Discrete Drain
16 catalogue numbers from 370016, listed by Aspen Surgical Products, Inc., United States, under Apparatus, Suction, Single Patient Use, Portable, Nonpowered. 58 manufacturers in China are registered for this product code.
58manufacturers in China registered for this device type
16catalogue numbers in this listing
21recalls on this code
Who Else Makes It
Concentrated in Jiangsu (19), Guangdong (14), Zhejiang (9). 15 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Firstar Healthcare Company Limited (Guangzhou) | Guangzhou | Guangdong | Contract manufacturer | 57 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Shun SZE Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 22 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| iBrite Suzhou Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Ningbo Albert Novosino Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Beilun Plastech Inc | Ningbo | Zhejiang | Contract manufacturer | 13 |
| Changshu Beyond Medical Device Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 9 |
| Fansheng Technology (Guangdong) Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 8 |
Showing 12 of 58. All 58 manufacturers in China registered for Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Record
| Listed by | Aspen Surgical Products, Inc., United States |
|---|---|
| FDA product code | GCY |
| Device type | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4680 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-02-25 |
| Record revised | 2022-03-08 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 370016 | In distribution | |
| 370019 | In distribution | |
| 370003 | In distribution | |
| 370020 | In distribution | |
| 370017 | In distribution | |
| 370021 | In distribution | |
| 370007 | In distribution | |
| 370001 | In distribution | |
| 370005 | In distribution | |
| 370018 | In distribution | |
| 370006 | In distribution | |
| 370022 | In distribution | |
| 370002 | In distribution | |
| 370004 | In distribution | |
| 370000 | In distribution | |
| 370023 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bioseal Inc. | Bioseal | 169 |
| Cardinal Health | Cardinal Health 200, LLC | 50 |
| Closed Suction | Sunset Healthcare Solutions, Inc. | 49 |
| Closed Wound Suction | C.R. Bard, Inc. | 37 |
| Barovac® Evacuator Closed Wound Drainage System(SS) | Sewoon Medical Co., Ltd. | 33 |
| Hemovac® Wound Drainage System | Zimmer Orthopaedic Surgical Products | 23 |
| Barovac® Evacuator Closed Wound Drainage System(PP) | Sewoon Medical Co., Ltd. | 22 |
| Deluxe Closed Suction System 72hr | Sunset Healthcare Solutions, Inc. | 20 |
| Tru-Close Suction Drainage System | Uresil, LLC | 19 |
| Deluxe Closed Suction System | Sunset Healthcare Solutions, Inc. | 19 |
| Tracheostomy and Suction Accessory | Sunset Healthcare Solutions, Inc. | 18 |
| S-Vac® Fluted Channel Drain | Aspen Surgical Products, Inc. | 17 |
Showing 12 of 110. All products under Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Recalls
19 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-03-20 | Class II | Packaging process control | The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. | 2014-11-25 | |
| 2014-03-20 | Class II | Packaging process control | The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. | 2014-11-25 | |
| 2014-03-20 | Class II | Packaging process control | The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. | 2014-11-25 | |
| 2014-03-20 | Class II | Packaging process control | The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. | 2014-11-25 | |
| 2014-03-20 | Class II | Packaging process control | The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. | 2014-11-25 | |
| 2014-03-20 | Class II | Packaging process control | The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. | 2014-11-25 | |
| 2014-03-20 | Class II | Packaging process control | The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. | 2014-11-25 | |
| 2014-03-20 | Class II | Packaging process control | The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. | 2014-11-25 | |
| 2014-03-20 | Class II | Packaging process control | The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. | 2014-11-25 | |
| 2014-03-20 | Class II | Packaging process control | The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. | 2014-11-25 | |
| 2014-03-20 | Class II | Packaging process control | The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. | 2014-11-25 | |
| 2014-03-20 | Class II | Packaging process control | The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. | 2014-11-25 | |
| 2014-03-20 | Class II | Packaging process control | The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. | 2014-11-25 | |
| 2014-03-20 | Class II | Packaging process control | The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. | 2014-11-25 | |
| 2014-03-20 | Class II | Packaging process control | The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. | 2014-11-25 | |
| 2014-03-20 | Class II | Packaging process control | The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. | 2014-11-25 | |
| 2014-03-20 | Class II | Packaging process control | The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. | 2014-11-25 | |
| 2014-03-20 | Class II | Packaging process control | The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. | 2014-11-25 | |
| 2014-03-20 | Class II | Packaging process control | The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. | 2014-11-25 | |
| 2009-04-13 | Not classified | Process change control | An adaptor, which may be required when connecting the drain to an external device, was not included in the package. | 9 cases of both products | 2009-11-23 |
| 2009-04-13 | Not classified | Process change control | An adaptor, which may be required when connecting the drain to an external device, was not included in the package. | 9 cases of both products | 2009-11-23 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.